Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Official Title ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

Brief Summary

Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patients with opioid dependence.

Received treatment for opioid dependence (e.g., methadone, BPN), within the previous 90 days

Current diagnosis of chronic pain requiring opioids for treatment

Candidates for only short term opioid treatment or opioid detoxification therapy

Pregnant or lactating females

Previous hypersensitivity or allergy to BPN- or EVA-containing substances or naloxone

Current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)

Current anti-coagulant therapy (such as warfarin) or an INR > 1.2

Meet DSM-IV criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)

Current use of benzodiazepines other than physician prescribed use

Significant medical or psychiatric symptoms or dementia which in the opinion of the Investigators would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent

Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in study

Participated in a clinical study within the previous 8 weeks

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects